Bial has announced that the European Medicines Agency (EMA) has accepted its application to review recent clinical trial data for Zebinix® (eslicarbazepine acetate) for its use as a once-daily monotherapy in the treatment of adult patients with newly diagnosed partial-onset (focal) epilepsy.

Application accepted to review recent clinical trial data for Zebinix

Partial-onset seizures, also known as focal, are the most common type and are therefore an important first target for treatment.[i] Zebinix®, (eslicarbazepine acetate) is currently indicated in Europe as an adjunctive therapy in adults with partial-onset seizures, with or without secondary generalisation.[ii] In the US, eslicarbazepine acetate (Aptiom®) is indicated for the treatment of partial-onset seizures as monotherapy or as an adjunctive therapy.[iii]

“We have been developing eslicarbazepine acetate for many years and it’s very encouraging to have the monotherapy submission acceptance”

Commenting on the submission António Portela, CEO of Bial, explains, “It is a significant milestone in Bial’s commitment to help people who live with epilepsy. We have been developing eslicarbazepine acetate for many years and it’s very encouraging to have the monotherapy submission acceptance. We hope it will become available for those living with epilepsy and for those who manage the condition”.

The submission was based on the results from a Bial sponsored Phase III study [4,5] in adult patients with newly diagnosed partial-onset seizures which demonstrates that treatment with monotherapy is as effective as controlled-release carbamazepine, a standard of care, and is well-tolerated.

This phase III study[iv],[v] is a randomised, double-blind, parallel-group, active-controlled and non-inferiority study, that investigates the efficacy and safety of once-daily eslicarbazepine acetate (800 to 1600 mg/daily) as monotherapy treatment for newly diagnosed adults (18 years and older) with partial-onset seizures in comparison with twice-daily controlled-release carbamazepine (400 to 1200 mg/daily). The primary endpoint was the proportion of people seizure free for the entire 26-week evaluation period. Secondary endpoints included the time to first seizure, a QOLIE-31 quality of life assessment, and safety. These data were recently presented for the first time at the Academy of Neurology Annual Meeting April 2016.

Efficacy analysis from this study[4] shows seizure freedom rates of 71% with eslicarbazepine acetate and 75.6% controlled-release carbamazepine in 785 eligible patients at ≥6 months at the last evaluated dose (average risk difference -4.28%, 95%CI -10.3, 1.74%). The one-year seizure-free rate at the last evaluated dose was 64.7% in the eslicarbazepine acetate group and 70.3% in the controlled-release carbamazepine group (average risk difference: -5.46%; 95%CI: -11.88, 0.97%).

Eslicarbazepine acetate is a voltage-gated sodium channel blocker. It selectively targets the slow inactivated state of the sodium ion channel[vi] which, stops sodium entering the nerve cells in the brain.[vii] This reduces the activity of the nerve cells, reducing the intensity and the number of seizures.[7]